Other extensive endocrinologic studies on pre-and postnatal testosterone and the presence of the testosterone-degrading enzyme aromatase, conducted before and after the publication of the Swedish researchers' work, have confirmed the significant role of increased anti-testosterone antibodies in subsequent male pregnancies.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee based its voting on a review of data from the comprehensive dapagliflozin global clinical development program included as part of the FDA New Drug Application submission.

Signifor is the first medicine to be approved in the US that addresses the underlying mechanism of Cushing's disease, a serious, debilitating endocrine disorder caused by the presence of a non-cancerous pituitary tumor which ultimately leads to excess cortisol in the body This approval follows a unanimous recommendation from the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) in support of the use of Signifor.

But during a 2-day meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, the members of the expert panel were asked whether such a study should be required for those therapies with no such signal in preapproval studies.

WASHINGTON -- Makers of antiobesity drugs might see looser requirements for approval if the Food and Drug Administration adopts the recommendations of its Endocrinologic and Metabolic Drugs Advisory Committee, which met in early September.

On October 16, 2012, two days prior to a meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee to decide on whether to recommend Kynamro for FDA approval, the FDA published a clinical briefing document questioning the safety and efficacy of Kynamro.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee panel came to this consensus at the end of a meeting called by the agency to review data from the trial and consider the implications of long-term use of these products for the prevention and/or treatment of postmenopausal osteoporosis.

All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical, or any other professional.